1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING Product information Product Name: MSDS Number: 122000007005 Use : Medicinal products Company BAYER HEALTHCARE LLC Consumer Care 36 Columbia Road Morristown, NJ 07962-1910 UNITED STATES (800) 743-5423 In case of emergency: (800) 331-4536 Chemtrec: (800) 424-9300 BAYER INFORMATION PHONE:(800) 331-4536 OR (800) 743-5423 2. HAZARDS IDENTIFICATION Emergency Overview Colour: clear, cloudy, colorless Form: liquid Odour: characteristic. Product poses little or no hazard if spilled and no unusual hazard if involved in a fire. See Potential Health Effects if the recommended dosage is exceeded. Appropriate route of entry: Topical application to skin This is a pharmaceutical material available without a prescription. Use only as directed. See carton for full directions and warnings. Hazard Communication (29CFR 1910.1200) Acute Ingestion Hazards Acute Effects of Exposure May cause nervous system effects which can include symptoms of dizziness, incoordination, headache, numbness, and/or confusion. Acute overdosage with topical application of this product is unlikely and would not be expected to lead to a life-threatening situation. No Carcinogenic substances as defined by IARC, NTP and/or OSHA Page 1 of 7
3. COMPOSITION/INFORMATION ON INGREDIENTS Weight percent Components CAS-No. 5-10% 57-55-6 Label Ingredients: Benzalkonium chloride; Lidocaine hydrochloride; Edetate Disodium; Camphor; Clove oil; Eucalyptus Oil; Marjoram Oil; Menthol; Nonoxynol 9; 1,2-Propylenglykol / 1,2-Propandiol; Water; 4. FIRST AID MEASURES General advice: Take off all contaminated clothing immediately. If inhaled: Remove to fresh air. Call a physician immediately. In case of skin contact: If skin reactions occur, contact a physician. In case of eye contact: In the case of contact with eyes, rinse immediately with plenty of water and seek medical advice. If swallowed: If swallowed, seek medical advice immediately and show this container or label. Contact Number: Use the Bayer Emergency Number in Section 1 5. FIRE-FIGHTING MEASURES Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Unsuitable extinguishing media: High volume water jet Specific hazards during fire fighting: Fire may cause evolution of: Carbon monoxide Carbon dioxide (CO2) Special protective equipment for fire-fighters: In the event of fire, wear self-contained breathing apparatus. Further information: Prevent fire extinguishing water from contaminating surface water or the ground water system. 6. ACCIDENTAL RELEASE MEASURES Page 2 of 7
Personal precautions: Use personal protective equipment. Use adequate ventilation. Methods for cleaning up: Suppress (knock down) gases/vapours/mists with a water spray jet. Soak up with inert absorbent material (e.g. sand, silica gel, acid binder, universal binder, sawdust). Place in closed containers. Label for proper disposal. Additional advice: Keep away from/remove sources of ignition. Further Accidental Release Notes Keep away from/remove sources of ignition. 7. HANDLING AND STORAGE Handling: Keep this and all drugs out of the reach of children. Avoid contact with skin, eyes and clothing. Wash... thoroughly after handling. Store in a dry place away from excessive heat. Reseal containers immediately after use. Use normal precautions for storage of a drug. Take measures to prevent the build up of electrostatic charge. Keep away from open flames, hot surfaces and sources of ignition. Storage: Storage temperature: 59-77 F (15-25 C) Do not use after expiration date. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Respiratory protection: Recommended Filter type: Organic vapor with prefilter Hand protection: Chemically resistant gloves. Eye protection: Protective goggles Other protective measures: Wear suitable protective equipment. 9. PHYSICAL AND CHEMICAL PROPERTIES Form: Colour: Odour: Boiling point/boiling range: Density: liquid clear, cloudy, colorless characteristic Page 3 of 7
Vapour pressure: Viscosity, dynamic: Miscibility with water: Water solubility: completely soluble ph: 6-6.8 Partition coefficient (n-octanol/water): Ignition temperature: not determined 10. STABILITY AND REACTIVITY Conditions to avoid: Materials to avoid: Oxidizing agents Hazardous reactions: None known. Thermal decomposition: Hazardous decomposition products: Carbon monoxide, Carbon dioxide (CO2) 11. TOXICOLOGICAL INFORMATION Acute oral toxicity: LD50 rat: 19400-36000 Acute dermal toxicity: LD50 rabbit: 20800 Skin irritation: rabbit slight irritation Eye irritation: rabbit slight irritation Page 4 of 7
Sensitisation: Human experience Result: not sensitizing Genotoxicity in vitro: Ames test Bacteria Result: negative Pharmaceutic effects: analgetic Antiseptic 12. ECOLOGICAL INFORMATION General advice: Do not allow to enter surface waters or groundwater. Toxicity to fish: Acute Fish toxicity: LC50 > 20,000 mg/l Test species: Pimephales promelas (fathead minnow) Duration of test: 96 h Toxicity to daphnia and other aquatic invertebrates: LC50 34,400 mg/l Test species: Daphnia magna (Water flea) Duration of test: 48 h Toxicity to bacteria: > 20,000 mg/l tested on: Pseudomonas putida Biodegradability: Readily biodegradable. 13. DISPOSAL CONSIDERATIONS If discarded in its purchased form, this product would not be a hazardous waste either by listing or by characteristic. However, under RCRA, it is the responsibility of the product user to determine at the time of disposal, whether a material containing the product or derived from the product should be classified as a hazardous waste. (40 CFR 261.20-24) Waste disposal should be in accordance with existing federal, state and local environmental control laws. 14. TRANSPORT INFORMATION Land transport (DOT) Page 5 of 7
Inland waterway transport Railway transport Sea transport (IMDG) Air transport (ICAO / IATA cargo aircraft only) Air transport (ICAO / IATA passenger and cargo aircraft) 15. REGULATORY INFORMATION US. EPA Emergency Planning and Community Right-To-Know Act (EPCRA) SARA Title III Section 302 Extremely Hazardous Substance (40 CFR 355, Appendix A) Components None US. EPA Emergency Planning and Community Right-To-Know Act (EPCRA) SARA Title III Section 313 Toxic Chemicals (40 CFR 372.65) - Supplier Notification Required Components None US. EPA CERCLA Hazardous Substances (40 CFR 302) Components None Massachusetts, New Jersey or Pennsylvania Right to Know Substance Lists Weight percent Components CAS-No. 5-10% 57-55-6 California Prop. 65 To the best of our knowledge, this product does not contain any of the listed chemicals, which the state of California has found to cause cancer, birth defects or other reproductive harm. OSHA Hazcom Standard Rating Hazardous 16. OTHER INFORMATION HMIS Rating Health 1 Page 6 of 7
Flammability 0 Physical Hazard 0 0=Minimal 1=Slight 2=Moderate 3=Serious 4=Severe * = Chronic Health Hazard Further information The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text. Page 7 of 7